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FDA OKs mHealth Platform to Help Care Providers Treat Concussions

The FDA has grated breakthrough device status to SyncThink's mHealth technology, which consists of a virtual reality headset and accompanying mobile health tablet. It's one of several connected care approaches aimed at helping doctors identify and treat concussions.

Source: ThinkStock

By Eric Wicklund

- Federal regulators have given their approval to an mHealth platform that uses virtual reality technology to improve care management for people suffering from a concussion.

The US Food and Drug Administration has granted breakthrough device designation to EYE-SYNC, a mobile health platform developed by Boston-based SyncThink. This latest approval follows the FDA’s clearance in 2016 of the technology for recording, viewing and analyzing eye movements in support of identifying visual tracking impairment in human subjects.

“With millions of concussions occurring each year the need for a rapid, mobile and, most importantly, objective metric for impairment and recovery is clear and we are thrilled that the FDA is recognizing the importance of this work” company CEO Laura Yecies said in a press release.

EYE-SYNC, which consists of a VR headset with infrared cameras and an mHealth app on a tablet, is used to assist clinicians in evaluating visual impairments, monitor recovery and support the rehabilitation of ocular-motor and ocular-vestibular deficits, and in the optimization of brain performance.

It’s one of several mHealth and telehealth programs aimed at helping providers identify and treat concussions, which affect between 1.6 million and 3.8 million people a year in just the sports and recreation fields, according to the Brain Injury Research Institute. Aside from AR and VR platforms, other technologies being put to use include telehealth and mHealth solutions – ranging from tablets to robots – that bring specialists to the primary care office, locker room or even the field of play to more quickly analyze an affected athlete, and digital health technology to aims to identify concussion symptoms from a drop of blood.

Late last year, Children’s National Medical Center announced that it was integrating the technology into its Safe Concussion Outcome Recovery and Education (SCORE) program, aimed at improving analysis and outcomes for those between the ages of six and 16 who suffer a concussion.

“The SCORE program at Children’s National was established in 2003 with the mission of promoting developmentally appropriate assessment and treatment for children with concussion,” Dr. Christopher Vaughan, assistant director of the SCORE program, said in a press release. “Measuring eye tracking in youth with the EYE-SYNC product may improve our multimodal and developmentally sensitive assessment process.”


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